Trial Outcomes & Findings for An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement (NCT NCT05948878)
NCT ID: NCT05948878
Last Updated: 2026-04-15
Results Overview
We will examine the maximum force the taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site.
COMPLETED
NA
32 participants
Until the tape is dislodged- approximately 15 seconds
2026-04-15
Participant Flow
Participant milestones
| Measure |
Retrograde Directional Test
Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
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90 Degrees Directional Test
Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
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|---|---|---|
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Overall Study
STARTED
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16
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16
|
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Overall Study
COMPLETED
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14
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16
|
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Overall Study
NOT COMPLETED
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2
|
0
|
Reasons for withdrawal
| Measure |
Retrograde Directional Test
Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
|
90 Degrees Directional Test
Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
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|---|---|---|
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Overall Study
Equipment failure
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2
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0
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Baseline Characteristics
Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
Baseline characteristics by cohort
| Measure |
Retrograde Directional Test
n=14 Participants
Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
Novel Taping Method: Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
BCH Emergency Department Taping Method: Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
Chevron Taping Method: Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
|
90 Degrees Directional Test
n=16 Participants
Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
Novel Taping Method: Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
BCH Emergency Department Taping Method: Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
Chevron Taping Method: Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
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Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
0 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
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0 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
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Age, Categorical
Between 18 and 65 years
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14 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
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16 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
30 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
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Age, Categorical
>=65 years
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0 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
0 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
0 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
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Sex: Female, Male
Female
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12 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
8 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
20 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
|
Sex: Female, Male
Male
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2 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
8 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
|
10 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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14 Participants
n=14 Participants • 2 participants were withdrawn due to equipment error.
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16 Participants
n=16 Participants • 2 participants were withdrawn due to equipment error.
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30 Participants
n=30 Participants • 2 participants were withdrawn due to equipment error.
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Acceptable Skin State
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14 Participants
n=14 Participants
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16 Participants
n=16 Participants
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30 Participants
n=30 Participants
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PRIMARY outcome
Timeframe: Until the tape is dislodged- approximately 15 secondsWe will examine the maximum force the taping methods can withstand as measured by the force gauge in the retrograde direction, distally from the insertion site.
Outcome measures
| Measure |
Novel Taping
n=30 Participants
The novel taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
|
Chevron Taping
n=30 Participants
The Chevron taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
|
ED Taping
n=30 Participants
The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
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|---|---|---|---|
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The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction.
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28.65 Newtons
Standard Deviation 8.15
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15.41 Newtons
Standard Deviation 4.22
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19.29 Newtons
Standard Deviation 6.81
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PRIMARY outcome
Timeframe: Until the tape is dislodged- approximately 15 secondsPopulation: Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
We will examine the maximum force the taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site.
Outcome measures
| Measure |
Novel Taping
n=30 Participants
The novel taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
|
Chevron Taping
n=30 Participants
The Chevron taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
|
ED Taping
n=30 Participants
The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
|
|---|---|---|---|
|
The Force (Newtons) Required to Dislodge an IV Catheter Secured in a 90 Degrees Direction.
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20.85 Newtons
Standard Deviation 6.51
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13.68 Newtons
Standard Deviation 4.02
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13.16 Newtons
Standard Deviation 4.55
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Adverse Events
Retrograde Directional Test: Novel Taping
Retrograde Directional Test: Chevron Taping
Retrograde Directional Test: ED Taping
90 Degrees Directional Test: Novel Taping
90 Degrees Directional Test: Chevron Taping
90 Degrees Directional Test: ED Taping
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place